We have a vacancy for a Medical Writer and a Clinical Lead/Chief Medical Officer
Blueberry’s vision is to bring high value, innovative medicines to the market that make a real difference to patients’ lives. We are now growing, and looking for a full time Clinical Lead or an experienced Chief Medical Officer to join our successful team. If you have the skills listed below, enjoy working in a dynamic, exciting environment, and really want to have a positive impact on patients’ lives, then we’d love to hear from you.
To recruitment companies: unsolicited emails, phone calls or CVs will not be acknowledged
As a Medical Writer, you will be familiar with documents such as clinical study reports and the common technical document (CTD), and will be able to evaluate scientific data objectively, in order to report results and scientific concepts in a concise and accurate manner. In addition, you will work closely with the Clinical team and Regulatory Affairs Director to lead the planning and delivery of regulatory submissions and other projects.
Tasks & Responsibilities:
- Preparation, editing, formatting and finalisation of the following documents:
- Clinical documents; such as Protocol, Protocol Amendment, ICF, PIS, IB, CSR
- Regulatory documents; such as IND, NDA (ISS/ISE), Briefing documents
- Safety documents; such as DSUR, PSUR, ASR, Case Narratives
- Scientific Publications; such as Manuscripts, Abstracts, White Papers
- Manage medical writing timelines with functional area timelines for assigned documents to ensure on-time deliverables.
- Communicate with document authors, owners, contributors, and reviewers of different functional areas internally and externally to ensure appropriate coordination of and input into medical writing tasks.
- Facilitate comment resolution with authors, reviewers, and project teams.
- Participate in the development of medical writing processes, SOPs, work instructions, templates, style and content guides, and document quality control to ensure efficient preparation of high-quality medical writing deliverables.
- Assist in the interviewing, mentoring, and integration of new staff.
- Build and manage external relationships in support of these tasks as appropriate.
- Minimum of 3-5 years Medical Writing experience at a lead author level in the following; Clinical documents, Regulatory documents, Safety documents, Scientific publications.
- Strong scientific background including a minimum of a BSc (or equivalent) in an appropriate scientific discipline.
- Familiarity with EU regulatory guidelines for document development with respect to structure, format, and content. Having this experience in the US would be an advantage.
- Excellent writing skills with comprehensive knowledge of drug development process and applicable regulatory guidelines.
- Excellent written and spoken English, and a good working understanding of clinical development and ICH guidelines for regulatory documents.
- Proven track record of working on drug development programmes from pre-clinical and early phase clinical through to marketing application.
- Proactive, well-developed project management skills, and confident and effective interpersonal skills.
- Flexibility for occasional travel within Europe.
- A strong team player with the flexibility and the willingness to get involved with other activities that support the development of our drug programs.
To apply for this role, please email your CV and covering letter to Susie Yau, Office Manager: firstname.lastname@example.org by Friday 26th July 2019.
Clinical Lead or Chief Medical Officer
The Clinical Lead/CMO will serve as the medical expert for assigned clinical trials and will provide input into the design and conduct of clinical trials, assessment and interpretation of safety data, and contribute to investigator training to secure safety and well-being of clinical research participants.
Tasks & Responsibilities:
- Protocol development and consulting with functions such as BioStats, Preclinical, Regulatory, QA, and the Exec team during protocol development
- Serve as the in-house subject matter expert and consult other groups as needed for decision-making
- Therapeutic training and consulting
- Medical review of informed consent and CRF design, clinical trial protocol and Investigator Brochure
- Development of individual study medical monitoring plans
- Site selection and enrolment enhancement solutions
- Key opinion leader network development
- Scientific and medical support for project management teams and sites
- Subject Listing and laboratory data review
- Medical data coding and review
- 24-hour on call medical monitoring for protocol queries and site support, or medical/safety issues
- Regulatory agency support and interface
- End of study tables and listings review and scientific manuscript drafting/review
- Reviewing all clinical deliverables, such as final narratives and clinical study reports
- Providing medical guidance to the internal team and to the trial sites by answering investigator questions about the protocol and the medical management of subject emergencies
- MD. or equivalent degree with experience in biomedical research and related safety and clinical trials issues
- Experience working as a physician
- 2-3 years relevant experience with the design and conduct of clinical research studies, particularly multi-center clinical trials
- Knowledge of pharmacovigilance, clinical safety regulations and guidelines, and clinical research trials methodology
- Knowledge of ICH/GCP guidelines
- Flexibility to travel internationally when needed
- Ability to communicate effectively with internal and external stakeholders and present findings
- Ability to independently identify problems and effectively offer solutions to problems
- Ability to comprehend, integrate and interpret scientific and medical data from a variety of sources
- Use innovative, creative approaches when necessary, to meet novel needs and/or solve problems
- Excellent personal integrity, highly organized, efficient, and detail-oriented
To apply for this role, please email your CV and covering letter to email@example.com